Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients
Phase 3
Completed
- Conditions
- Type2 Diabetes
- Interventions
- Registration Number
- NCT06329674
- Lead Sponsor
- AJU Pharm Co., Ltd.
- Brief Summary
A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 235
Inclusion Criteria
- Those who voluntarily signed the informed consent to participate in this study.
- Adults aged 19-75 years.
- Those diagnosed with type 2 diabetes mellitus.
- 7% ≤ HbA1c ≤ 10.5%
- FPG ≤ 270 mg/dL
- BMI ≤ 40 kg/㎡
- Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.
Exclusion Criteria
- Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
- Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
- Those with a history of malignant tumor within 5 years
- Those who have a clinically significant liver disease
- Those who have a clinically significant renal disease
- SBP > 180 mmHg or DBP > 110 mmHg
- Those who had allergic reaction to main ingredients or components of the investigational products.
- Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
- Females who are pregnant or breastfeeding.
- AST or ALT ≥ LRN*3
- TG ≥ 500 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AJU-A51 placebo+A51R2+A51R3 A51R3 - AJU-A51 placebo+A51R2+A51R3 A51R2 - AJU-A51+A51R2 placebo+A51R3 A51R2 Placebo - AJU-A51 placebo+A51R2+A51R3 AJU-A51 Placebo - AJU-A51+A51R2 placebo+A51R3 A51R3 - AJU-A51+A51R2 placebo+A51R3 AJU-A51 -
- Primary Outcome Measures
Name Time Method Changes in HbA1c 24th week Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of